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TAVANIC 250MG TABLETS

Active substance(s): LEVOFLOXACIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Tavanic 250mg Tablets
(levofloxacin)

Tavanic Tablets are available in the following strengths:
250mg and 500mg. The name of your medicine is Tavanic
250mg Tablets but will be referred to as Tavanic throughout
this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.







Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Tavanic is and what it is used for
What you need to know before you take Tavanic
How to take Tavanic
Possible side effects
How to store Tavanic
Contents of the pack and other information

1. What Tavanic is and what it is used for
The name of your medicine is Tavanic. Tavanic contains a
medicine called levofloxacin. This belongs to a group of
medicines called antibiotics. Levofloxacin is a ‘quinolone’
antibiotic. It works by killing the bacteria that cause infections
in your body.

Tavanic can be used to treat infections of the:







Sinuses
Lungs, in people with long-term breathing problems or
pneumonia
Urinary tract, including your kidneys or bladder
Prostate gland, where you have a long lasting infection
Skin and underneath the skin, including muscles. This is
sometimes called ‘soft tissue’

In some special situations, Tavanic may be used to lessen the
chances of getting a pulmonary disease named anthrax or
worsening of the disease after you are exposed to the
bacteria causing anthrax.

2. What you need to know before you take
Tavanic
Do not take this medicine and tell your doctor if:











You are allergic to levofloxacin, any other quinolone
antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin
or any of the other ingredients of this medicine (listed in
section 6)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue
You have ever had epilepsy
You have ever had a problem with your tendons such as
tendonitis that was related to treatment with a
‘quinolone antibiotic’. A tendon is the cord that joins
your muscle to your skeleton
You are a child or a growing teenager
You are pregnant, might become pregnant or think you
may be pregnant
You are breast-feeding

Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
taking Tavanic.

Warnings and precautions
Talk to your doctor or pharmacist before taking
your medicine if:







You are 60 years of age or older
You are using corticosteroids, sometimes called steroids
(see section “Other medicines and Tavanic”)
You have ever had a fit (seizure)
You have had damage to your brain due to a stroke or
other brain injury
You have kidney problems

You have something known as ‘glucose – 6 – phosphate
dehydrogenase deficiency’. You are more likely to have
serious problems with your blood when taking this
medicine

You have ever had mental health problems

You have ever had heart problems: caution should be
taken when using this kind of medicine, if you were born
with or have family history of prolonged QT interval
(seen on ECG, electrical recording of the heart), have
salt imbalance in the blood (especially low level of
potassium or magnesium in the blood), have a very slow
heart rhythm (called ‘bradycardia’), have a weak heart
(heart failure), have a history of heart attack
(myocardial infarction), you are female or elderly or you
are taking other medicines that result in abnormal ECG
changes (see section “Other medicines and Tavanic”)

You are diabetic

You have ever had liver problems

You have myasthenia gravis
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Tavanic.


Other medicines and Tavanic

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This is because
Tavanic can affect the way some other medicines work. Also
some medicines can affect the way Tavanic works.
In particular, tell your doctor if you are taking any of
the following medicines. This is because it can increase
the chance of you getting side effects, when taken with
Tavanic:

Corticosteroids, sometimes called steroids – used for
inflammation. You may be more likely to have
inflammation and/or rupture of your tendons.

Warfarin - used to thin the blood. You may be more
likely to have a bleed. Your doctor may need to take
regular blood tests to check how well your blood can
clot.

Theophylline - used for breathing problems. You are
more likely to have a fit (seizure) if taken with Tavanic.

Non-steroidal anti-inflammatory drugs (NSAIDS) - used
for pain and inflammation such as aspirin, ibuprofen,
fenbufen, ketoprofen and indomethacin. You are more
likely to have a fit (seizure) if taken with Tavanic.

Ciclosporin - used after organ transplants. You may be
more likely to get the side effects of ciclosporin.

Medicines known to affect the way your heart beats.
This includes medicines used for abnormal heart rhythm
(antiarrhythmics such as quinidine, hydroquinidine,
disopyramide, sotalol, dofetilide, ibutilide and
amiodarone), for depression (tricyclic antidepressants
such as amitriptyline and imipramine,), for psychiatric
disorders (antipsychotics), and for bacterial infections
(‘macrolide’ antibiotics such as erythromycin,
azithromycin and clarithromycin).

Probenecid – used for gout. Your doctor may want to
give you a lower dose if you have kidney problems.

Cimetidine – used for ulcers and heartburn. Your doctor
may want to use a lower dose, if you have kidney
problems.
Tell your doctor if any of the above applies to you.
Do not take Tavanic at the same time as the following
medicines. This is because it can affect the way Tavanic
work:

Iron tablets (for anaemia), zinc supplements,
magnesium or aluminium-containing antacids (for acid
or heartburn), didanosine, or sucralfate (for stomach
ulcers). See Section 3 “If you are already taking iron
tablets, zinc supplements, antacids, didanosine or
sucralfate”.

Urine tests for opiates

Urine tests may show ‘false-positive’ results for strong
painkillers called ‘opiates’ in people taking Tavanic. If your
doctor has prescribed a urine test, tell your doctor you are
taking Tavanic.

Tuberculosis tests

This medicine may cause “false-negative” results for some
laboratory tests that search for the bacteria that cause
tuberculosis.

Pregnancy and breast-feeding

Do not take this medicine if:

You are pregnant, might become pregnant or think you
may be pregnant

You are breast-feeding or planning to breast-feed

Page 1 of 2

Driving and using machines

You may get side effects after taking this medicine, including
feeling dizzy, sleepy, a spinning feeling (vertigo) or changes
to your eyesight. Some of these side effects can affect you
being able to concentrate and your reaction speed. If this
happens, do not drive or carry out any work that requires a
high level of attention.

3. How to take Tavanic
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

Taking this medicine




Take this medicine by mouth
Swallow the tablets whole with a drink of water
The tablets may be taken during meals or at any time
between meals

If you are already taking iron tablets, zinc
supplements, antacids, didanosine or sucralfate


Do not take these medicines at the same time as
Tavanic. Take your dose of these medicines at least 2
hours before or after Tavanic.

How much to take





Your doctor will decide on how many Tavanic you should
take
The dose will depend on the type of infection you have
and where the infection is in your body
The length of your treatment will depend on how serious
your infection is
If you feel the effect of your medicine is too weak or
strong, do not change the dose yourself, but ask your
doctor

Adults and the elderly
Sinuses infection




Two tablets of Tavanic 250mg, once each day
Or, one tablet of Tavanic 500mg, once each day

Lungs infection, in people with long-term breathing
problems




Two tablets of Tavanic 250mg, once each day
Or, one tablet of Tavanic 500mg, once each day

Pneumonia



Two tablets of Tavanic 250mg, once or twice each day
Or, one tablet of Tavanic 500mg, once or twice each day

Infection of urinary tract, including your kidneys or
bladder



One or two tablets of Tavanic 250mg, once each day
Or, ½ or one tablet of Tavanic 500mg, once each day

Prostate gland infection




Two tablets of Tavanic 250mg, once each day
Or, one tablet of Tavanic 500mg, once each day

Infection of skin and underneath the skin, including
muscles



Two tablets of Tavanic 250mg, once or twice each day
Or, one tablet of Tavanic 500mg, once or twice each day

Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.

Children and teenagers

This medicine must not be given to children or teenagers.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for
2 days after you stop taking it. This is because your skin will
become much more sensitive to the sun and may burn, tingle
or severely blister if you do not take the following
precautions:

Make sure you use high factor sun cream

Always wear a hat and clothes which cover your arms
and legs

Avoid sun beds

If you take more Tavanic than you should

If you accidentally take more tablets than you should, tell a
doctor or get other medical advice straight away. Take the
medicine pack with you. This is so the doctor knows what you
have taken. The following effects may happen: convulsive fits
(seizures), feeling confused, dizzy, less conscious, having
tremor and heart problems - leading to uneven heart beats as
well as feeling sick (nausea) or having stomach burning.

If you forget to take Tavanic







If you forgot to take a dose, take it as soon as you remember
unless it is nearly time for your next dose.
Do not double-up the next dose to make up for the missed
dose.



If you stop taking Tavanic





Do not stop taking Tavanic just because you feel better. It is
important that you complete the course of tablets that your
doctor has prescribed for you. If you stop taking the tablets
too soon, the infection may return, your condition may get
worse or the bacteria may become resistant to the medicine.

Rare (may affect up to 1 in 1,000 people)




If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.



4. Possible side effects




Like all medicines, this medicine can cause side effects,
although not everybody gets them. These effects are
normally mild or moderate and often disappear after a short
time.

Stop taking Tavanic and see a doctor or go to a
hospital straight away if you notice the following
side effect:
Very rare (may affect up to 1 in 10,000 people)


You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat, or tongue


















Watery diarrhoea which may have blood in it, possibly
with stomach cramps and a high temperature. These
could be signs of a severe bowel problem
Pain and inflammation in your tendons or ligaments,
which could lead to rupture. The Achilles tendon is
affected most often
Fits (convulsions)

Very rare (may affect up to 1 in 10,000 people)


Burning, tingling, pain or numbness. These may be signs
of something called ‘neuropathy’

Not known (frequency cannot be estimated from the
available data)




Severe skin rashes which may include blistering or
peeling of the skin around your lips, eyes, mouth, nose
and genitals
Loss of appetite, skin and eyes becoming yellow in
colour, dark-coloured urine, itching, or tender stomach
(abdomen). These may be signs of liver problems which
may include a fatal failure of the liver

If your eyesight becomes impaired or if you have any other
eye disturbances whilst taking Tavanic, consult an eye
specialist immediately.

Tell your doctor if any of the following side effects
gets serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)





Sleeping problems
Headache, feeling dizzy
Feeling sick (nausea, vomiting) and diarrhoea
Increase in the level of some liver enzymes in your
blood

Uncommon may affect up to 1 in 100 people)








Changes in the number of other bacteria or fungi,
infection by fungi named Candida, which may need to be
treated
Changes in the number of white blood cells shown up in
the results of some blood tests (leukopenia,
eosinophilia)
Feeling stressed (anxiety), feeling confused, feeling
nervous, feeling sleepy, trembling, a spinning feeling
(vertigo)
Shortness of breath (dyspnoea)

Bruising and bleeding easily due to a lowering in the
number of blood platelets (thrombocytopenia)
Low number of white blood cells (neutropenia)
Exaggerated immune response (hypersensitivity)
Lowering of your blood sugar levels (hypoglycaemia).
This is important for people that have diabetes
Seeing or hearing things that are not there
(hallucinations, paranoia), change in your opinion and
thoughts (psychotic reactions) with a risk of having
suicidal thoughts or actions
Feeling depressed, mental problems, feeling restless
(agitation), abnormal dreams or nightmares
Tingly feeling in your hands and feet (paraesthesia)
Problems with your hearing (tinnitus) or eyesight
(blurred vision)
Unusual fast beating of your heart (tachycardia) or low
blood pressure (hypotension)
Muscle weakness. This is important in people with
myasthenia gravis (a rare disease of the nervous
system)
Changes in the way your kidney works and occasional
kidney failure which may be due to an allergic kidney
reaction called interstitial nephritis
Fever

Not known (frequency cannot be estimated from the
available data)

Stop taking Tavanic and see a doctor straight away
if you notice any of the following serious side
effects - you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)


Changes in the way things taste, loss of appetite,
stomach upset or indigestion (dyspepsia), pain in your
stomach area, feeling bloated (flatulence) or
constipation
Itching and skin rash, severe itching or hives (urticaria),
sweating too much (hyperhidrosis)
Joint pain or muscle pain
Blood tests may show unusual results due to liver
(bilirubin increased) or kidney (creatinine increased)
problems
General weakness





















Lowering in red blood cells (anaemia): this can make the
skin pale or yellow due to damage of the red blood cells;
lowering in the number of all types of blood cells
(pancytopenia)
Fever, sore throat and a general feeling of being unwell
that does not go away. This may be due to a lowering in
the number of white blood cells (agranulocytosis)
Loss of circulation (anaphylactic like shock)
Increase of your blood sugar levels (hyperglycaemia) or
lowering of your blood sugar levels leading to coma
(hypoglycaemic coma). This is important for people that
have diabetes
Changes in the way things smell, loss of smell or taste
(parosmia, anosmia, ageusia)
Problems moving and walking (dyskinesia,
extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision, inflammation of the eye
Impairment or loss of hearing
Abnormal fast heart rhythm, life-threatening irregular
heart rhythm including cardiac arrest, alteration of the
heart rhythm (called ‘prolongation of QT interval’, seen
on ECG, electrical activity of the heart)
Difficulty breathing or wheezing (bronchospasm)
Allergic lung reactions
Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of your skin to sun and ultraviolet
light (photosensitivity)
Inflammation of the vessels that carry blood around
your body due to an allergic reaction (vasculitis)
Inflammation of the tissue inside the mouth (stomatitis)
Muscle rupture and muscle destruction (rhabdomyolysis)
Joint redness and swelling (arthritis)
Pain, including pain in the back, chest and extremities
Attacks of porphyria in people who already have
porphyria (a very rare metabolic disease)
Persistent headache with or without blurred vision
(benign intracranial hypertension)

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Page 2 of 2

5. How to store Tavanic
Keep out of the sight and reach of children.
No special precautions are required but it is best to keep
Tavanic tablets in the original strips and box in a dry place.
Do not use the tablets after the expiry date shown on the
carton and blister label. The expiry date refers to the last day
of that month.
If the tablets go out of date, take them to your pharmacist so
that he can get rid of them safely.
If your tablets become discoloured or deformed, take them
back to your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Tavanic contains

Each film-coated tablet contains 250mg of the active
ingredient levofloxacin equivalent to 256.23mg of
levofloxacin hemihydrate.
They also contain the following excipients:
crospovidone, hypromellose, microcrystalline cellulose,
sodium stearyl fumarate, titanium dioxide (E171), talc,
macrogol 8000, yellow ferric oxide (E172) and
red ferric oxide (E172).

What Tavanic looks like and contents of the pack

Your tablets are pale pink, oblong shaped film-coated tablets
with a scoreline on each side.
They are available in blister packs of 5 and 10 tablets.

Manufacturer

Manufactured by: Aventis Pharma Deutschland GmbH,
Frankfurt am Main, Germany.
Or
Sanofi Winthrop Industrie, 56, route de Choisy-au-Bac,
F-60205 Compiegne, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0448

POM

Leaflet revision & issue date (ref): 06.05.16
To listen to or request a copy of this leaflet in braille,
large print or audio please call: 01302 365000
Please be ready to give the following information:
Product name:
Tavanic 250mg tablets
Reference number:
PL No: 08929/0448
Tavanic® is a registered trademark of Daiichi Sankyo
Company, Limited.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin 250mg Tablets
Levofloxacin Tablets are available in the following strengths:
250mg and 500mg. The name of your medicine is
Levofloxacin 250mg Tablets but will be referred to as
Levofloxacin throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.







Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Levofloxacin is and what it is used for
What you need to know before you take Levofloxacin
How to take Levofloxacin
Possible side effects
How to store Levofloxacin
Contents of the pack and other information

1. What Levofloxacin is and what it is used
for
The name of your medicine is Levofloxacin. Levofloxacin
contains a medicine called levofloxacin. This belongs to a
group of medicines called antibiotics. Levofloxacin is a
‘quinolone’ antibiotic. It works by killing the bacteria that
cause infections in your body.

Levofloxacin can be used to treat infections of the:







Sinuses
Lungs, in people with long-term breathing problems or
pneumonia
Urinary tract, including your kidneys or bladder
Prostate gland, where you have a long lasting infection
Skin and underneath the skin, including muscles. This is
sometimes called ‘soft tissue’

In some special situations, Levofloxacin may be used to
lessen the chances of getting a pulmonary disease named
anthrax or worsening of the disease after you are exposed to
the bacteria causing anthrax.

2. What you need to know before you take
Levofloxacin
Do not take this medicine and tell your doctor if:











You are allergic to levofloxacin, any other quinolone
antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin
or any of the other ingredients of this medicine (listed in
section 6)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue
You have ever had epilepsy
You have ever had a problem with your tendons such as
tendonitis that was related to treatment with a
‘quinolone antibiotic’. A tendon is the cord that joins
your muscle to your skeleton
You are a child or a growing teenager
You are pregnant, might become pregnant or think you
may be pregnant
You are breast-feeding

Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
taking Levofloxacin.

Warnings and precautions
Talk to your doctor or pharmacist before taking
your medicine if:






You are 60 years of age or older
You are using corticosteroids, sometimes called steroids
(see section “Other medicines and Levofloxacin”)
You have ever had a fit (seizure)
You have had damage to your brain due to a stroke or
other brain injury
You have kidney problems

You have something known as ‘glucose – 6 – phosphate
dehydrogenase deficiency’. You are more likely to have
serious problems with your blood when taking this
medicine

You have ever had mental health problems

You have ever had heart problems: caution should be
taken when using this kind of medicine, if you were born
with or have family history of prolonged QT interval
(seen on ECG, electrical recording of the heart), have
salt imbalance in the blood (especially low level of
potassium or magnesium in the blood), have a very slow
heart rhythm (called ‘bradycardia’), have a weak heart
(heart failure), have a history of heart attack
(myocardial infarction), you are female or elderly or you
are taking other medicines that result in abnormal ECG
changes (see section “Other medicines and
Levofloxacin”)

You are diabetic

You have ever had liver problems

You have myasthenia gravis
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Levofloxacin.

Driving and using machines

Other medicines and Levofloxacin





Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This is because
Levofloxacin can affect the way some other medicines work.
Also some medicines can affect the way Levofloxacin works.
In particular, tell your doctor if you are taking any of
the following medicines. This is because it can increase
the chance of you getting side effects, when taken with
Levofloxacin:

Corticosteroids, sometimes called steroids – used for
inflammation. You may be more likely to have
inflammation and/or rupture of your tendons.

Warfarin - used to thin the blood. You may be more
likely to have a bleed. Your doctor may need to take
regular blood tests to check how well your blood can
clot.

Theophylline - used for breathing problems. You are
more likely to have a fit (seizure) if taken with
Levofloxacin.

Non-steroidal anti-inflammatory drugs (NSAIDS) - used
for pain and inflammation such as aspirin, ibuprofen,
fenbufen, ketoprofen and indomethacin. You are more
likely to have a fit (seizure) if taken with Levofloxacin.

Ciclosporin - used after organ transplants. You may be
more likely to get the side effects of ciclosporin.

Medicines known to affect the way your heart beats.
This includes medicines used for abnormal heart rhythm
(antiarrhythmics such as quinidine, hydroquinidine,
disopyramide, sotalol, dofetilide, ibutilide and
amiodarone), for depression (tricyclic antidepressants
such as amitriptyline and imipramine,), for psychiatric
disorders (antipsychotics), and for bacterial infections
(‘macrolide’ antibiotics such as erythromycin,
azithromycin and clarithromycin).

Probenecid – used for gout. Your doctor may want to
give you a lower dose if you have kidney problems.

Cimetidine – used for ulcers and heartburn. Your doctor
may want to use a lower dose, if you have kidney
problems.
Tell your doctor if any of the above applies to you.

You may get side effects after taking this medicine, including
feeling dizzy, sleepy, a spinning feeling (vertigo) or changes
to your eyesight. Some of these side effects can affect you
being able to concentrate and your reaction speed. If this
happens, do not drive or carry out any work that requires a
high level of attention.

3. How to take Levofloxacin
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

Taking this medicine




Take this medicine by mouth
Swallow the tablets whole with a drink of water
The tablets may be taken during meals or at any time
between meals

If you are already taking iron tablets, zinc
supplements, antacids, didanosine or sucralfate

Do not take these medicines at the same time as
Levofloxacin. Take your dose of these medicines at least
2 hours before or after Levofloxacin.

How much to take





Your doctor will decide on how many Levofloxacin you
should take
The dose will depend on the type of infection you have
and where the infection is in your body
The length of your treatment will depend on how serious
your infection is
If you feel the effect of your medicine is too weak or
strong, do not change the dose yourself, but ask your
doctor

Adults and the elderly
Sinuses infection



Two tablets of Levofloxacin 250mg, once each day
Or, one tablet of Levofloxacin 500mg, once each day

Lungs infection, in people with long-term breathing
problems



Two tablets of Levofloxacin 250mg, once each day
Or, one tablet of Levofloxacin 500mg, once each day

Pneumonia



Two tablets of Levofloxacin 250mg, once or twice each
day
Or, one tablet of Levofloxacin 500mg, once or twice
each day

Infection of urinary tract, including your kidneys or
bladder



One or two tablets of Levofloxacin 250mg, once each
day
Or, ½ or one tablet of Levofloxacin 500mg, once each
day

Prostate gland infection



Two tablets of Levofloxacin 250mg, once each day
Or, one tablet of Levofloxacin 500mg, once each day

Do not take Levofloxacin at the same time as the
following medicines. This is because it can affect the
way Levofloxacin work:

Iron tablets (for anaemia), zinc supplements,
magnesium or aluminium-containing antacids (for acid
or heartburn), didanosine, or sucralfate (for stomach
ulcers). See Section 3 “If you are already taking iron
tablets, zinc supplements, antacids, didanosine or
sucralfate”.

Infection of skin and underneath the skin, including
muscles

Urine tests for opiates

Children and teenagers

Urine tests may show ‘false-positive’ results for strong
painkillers called ‘opiates’ in people taking Levofloxacin. If
your doctor has prescribed a urine test, tell your doctor you
are taking Levofloxacin.

Tuberculosis tests

This medicine may cause “false-negative” results for some
laboratory tests that search for the bacteria that cause
tuberculosis.

Pregnancy and breast-feeding

Do not take this medicine if:

You are pregnant, might become pregnant or think you
may be pregnant

You are breast-feeding or planning to breast-feed
Page 1 of 2




Two tablets of Levofloxacin 250mg, once or twice each
day
Or, one tablet of Levofloxacin 500mg, once or twice
each day

Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.

This medicine must not be given to children or teenagers.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for
2 days after you stop taking it. This is because your skin will
become much more sensitive to the sun and may burn, tingle
or severely blister if you do not take the following
precautions:

Make sure you use high factor sun cream

Always wear a hat and clothes which cover your arms
and legs

Avoid sun beds

If you take more Levofloxacin than you should

If you accidentally take more tablets than you should, tell a
doctor or get other medical advice straight away. Take the
medicine pack with you. This is so the doctor knows what you
have taken. The following effects may happen: convulsive fits
(seizures), feeling confused, dizzy, less conscious, having
tremor and heart problems - leading to uneven heart beats as
well as feeling sick (nausea) or having stomach burning.

If you forget to take Levofloxacin







If you forgot to take a dose, take it as soon as you remember
unless it is nearly time for your next dose.
Do not double-up the next dose to make up for the missed
dose.



If you stop taking Levofloxacin





Do not stop taking Levofloxacin just because you feel better.
It is important that you complete the course of tablets that
your doctor has prescribed for you. If you stop taking the
tablets too soon, the infection may return, your condition may
get worse or the bacteria may become resistant to the
medicine.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects

Rare (may affect up to 1 in 1,000 people)








Like all medicines, this medicine can cause side effects,
although not everybody gets them. These effects are
normally mild or moderate and often disappear after a short
time.



Stop taking Levofloxacin and see a doctor or go to a
hospital straight away if you notice the following
side effect:
Very rare (may affect up to 1 in 10,000 people)





You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat, or tongue

Stop taking Levofloxacin and see a doctor straight
away if you notice any of the following serious side
effects - you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)






Watery diarrhoea which may have blood in it, possibly
with stomach cramps and a high temperature. These
could be signs of a severe bowel problem
Pain and inflammation in your tendons or ligaments,
which could lead to rupture. The Achilles tendon is
affected most often
Fits (convulsions)







If your eyesight becomes impaired or if you have any other
eye disturbances whilst taking Levofloxacin, consult an eye
specialist immediately.

Tell your doctor if any of the following side effects
gets serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)






Sleeping problems
Headache, feeling dizzy
Feeling sick (nausea, vomiting) and diarrhoea
Increase in the level of some liver enzymes in your
blood

Uncommon may affect up to 1 in 100 people)








Changes in the number of other bacteria or fungi,
infection by fungi named Candida, which may need to be
treated
Changes in the number of white blood cells shown up in
the results of some blood tests (leukopenia,
eosinophilia)
Feeling stressed (anxiety), feeling confused, feeling
nervous, feeling sleepy, trembling, a spinning feeling
(vertigo)
Shortness of breath (dyspnoea)

What Levofloxacin contains

Each film-coated tablet contains 250mg of the active
ingredient levofloxacin equivalent to 256.23mg of
levofloxacin hemihydrate.
They also contain the following excipients:
crospovidone, hypromellose, microcrystalline cellulose,
sodium stearyl fumarate, titanium dioxide (E171), talc,
macrogol 8000, yellow ferric oxide (E172) and
red ferric oxide (E172).

What Levofloxacin looks like and contents of the
pack

Your tablets are pale pink, oblong shaped film-coated tablets
with a scoreline on each side.
They are available in blister packs of 5 and 10 tablets.

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.






Not known (frequency cannot be estimated from the
available data)

Severe skin rashes which may include blistering or
peeling of the skin around your lips, eyes, mouth, nose
and genitals
Loss of appetite, skin and eyes becoming yellow in
colour, dark-coloured urine, itching, or tender stomach
(abdomen). These may be signs of liver problems which
may include a fatal failure of the liver

6. Contents of the pack and other
information












Keep out of the sight and reach of children.
No special precautions are required but it is best to keep
Levofloxacin tablets in the original strips and box in a dry
place.
Do not use the tablets after the expiry date shown on the
carton and blister label. The expiry date refers to the last day
of that month.
If the tablets go out of date, take them to your pharmacist so
that he can get rid of them safely.
If your tablets become discoloured or deformed, take them
back to your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Manufacturer



Burning, tingling, pain or numbness. These may be signs
of something called ‘neuropathy’

Bruising and bleeding easily due to a lowering in the
number of blood platelets (thrombocytopenia)
Low number of white blood cells (neutropenia)
Exaggerated immune response (hypersensitivity)
Lowering of your blood sugar levels (hypoglycaemia).
This is important for people that have diabetes
Seeing or hearing things that are not there
(hallucinations, paranoia), change in your opinion and
thoughts (psychotic reactions) with a risk of having
suicidal thoughts or actions
Feeling depressed, mental problems, feeling restless
(agitation), abnormal dreams or nightmares
Tingly feeling in your hands and feet (paraesthesia)
Problems with your hearing (tinnitus) or eyesight
(blurred vision)
Unusual fast beating of your heart (tachycardia) or low
blood pressure (hypotension)
Muscle weakness. This is important in people with
myasthenia gravis (a rare disease of the nervous
system)
Changes in the way your kidney works and occasional
kidney failure which may be due to an allergic kidney
reaction called interstitial nephritis
Fever

5. How to store Levofloxacin

Not known (frequency cannot be estimated from the
available data)

Very rare (may affect up to 1 in 10,000 people)


Changes in the way things taste, loss of appetite,
stomach upset or indigestion (dyspepsia), pain in your
stomach area, feeling bloated (flatulence) or
constipation
Itching and skin rash, severe itching or hives (urticaria),
sweating too much (hyperhidrosis)
Joint pain or muscle pain
Blood tests may show unusual results due to liver
(bilirubin increased) or kidney (creatinine increased)
problems
General weakness














Lowering in red blood cells (anaemia): this can make the
skin pale or yellow due to damage of the red blood cells;
lowering in the number of all types of blood cells
(pancytopenia)
Fever, sore throat and a general feeling of being unwell
that does not go away. This may be due to a lowering in
the number of white blood cells (agranulocytosis)
Loss of circulation (anaphylactic like shock)
Increase of your blood sugar levels (hyperglycaemia) or
lowering of your blood sugar levels leading to coma
(hypoglycaemic coma). This is important for people that
have diabetes
Changes in the way things smell, loss of smell or taste
(parosmia, anosmia, ageusia)
Problems moving and walking (dyskinesia,
extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision, inflammation of the eye
Impairment or loss of hearing
Abnormal fast heart rhythm, life-threatening irregular
heart rhythm including cardiac arrest, alteration of the
heart rhythm (called ‘prolongation of QT interval’, seen
on ECG, electrical activity of the heart)
Difficulty breathing or wheezing (bronchospasm)
Allergic lung reactions
Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of your skin to sun and ultraviolet
light (photosensitivity)
Inflammation of the vessels that carry blood around
your body due to an allergic reaction (vasculitis)
Inflammation of the tissue inside the mouth (stomatitis)
Muscle rupture and muscle destruction (rhabdomyolysis)
Joint redness and swelling (arthritis)
Pain, including pain in the back, chest and extremities
Attacks of porphyria in people who already have
porphyria (a very rare metabolic disease)
Persistent headache with or without blurred vision
(benign intracranial hypertension)

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Page 2 of 2

Manufactured by: Aventis Pharma Deutschland GmbH,
Frankfurt am Main, Germany.
Or
Sanofi Winthrop Industrie, 56, route de Choisy-au-Bac,
F-60205 Compiegne, France.

Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 08929/0448

POM

Leaflet revision & issue date (ref): 06.05.16
To listen to or request a copy of this leaflet in braille,
large print or audio please call: 01302 365000
Please be ready to give the following information:
Product name:
Levofloxacin 250mg tablets
Reference number:
PL No: 08929/0448

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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